HIPPIE: Hemodynamic Instability Prevented With Polaramine® Infusion Before Extracorporeal Circulation

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Completed

CT.gov ID

NCT02675374

Collaborator

(none)

Enrollment

Location

Arms

13.4

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This single-institution randomized controlled trial prospective will enrolled 48 patients scheduled for an aortic valve replacement. The objective of the present investigation is to determine the role of Polaramine® on reducing hemodynamic instability after separation from cardiopulmonary bypass (CPB) during cardiac surgery. Our hypothesis is that Polaramine® play an important role reducing dysfunction of the autonomic nervous system and hemodynamic stability after separation from CPB.

Condition or Disease	Intervention/Treatment	Phase
Hemodynamic Instability Vasoplegic Syndrome	Drug: dexchlorpheniramine (Polaramine®) injection Drug: Placebo injection	Phase 3

Detailed Description

Vasoplegic syndrome is recognized as a common complication after CPB. Its incidence ranges from 5% to 25% after cardiac surgery requiring CPB. Such syndrome is related to an inflammatory reaction, which is attributed to the CPB. This syndrome is typically characterized by a combination of different parameters with low specificity and sensitivity, such as low systemic vascular resistance leading to a hypotension imposing perfusion of vasopressors with high or normal cardiac outputs.

Investigators preliminary data suggest that vasoplegic syndrome might be related to heart manipulation during surgery. Tearing maneuvers performed on the heart chambers trigger peaks pressure stimulating, consequently, baroreceptors and finally resulting in arteriovenous vasodilation via neurogenic and endogenous pathways. According to investigators initial investigation, such reaction appears to be related to basophils degranulation and release of vasoactive substances.

The hypothesis of the present trial is that a reduction of basophils degranulation and release of vasoactive substances via an antihistaminic could lower the incidence of the vasoplegic syndrome. This study aims to determine the effect of an antihistamine (dexchlorpheniramine (Polaramine®)) administered intravenously before CPB, on the vasoplegic syndrome incidence after separation from CPB.

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Actual Study Start Date :

Jun 5, 2016

Actual Primary Completion Date :

Jul 18, 2017

Actual Study Completion Date :

Jul 18, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment group 24 patients	Drug: dexchlorpheniramine (Polaramine®) injection 5 minutes before CPB, patients will receive 10 mg (2 ml) of Polaramine®
Placebo Comparator: Control group 24 patients	Drug: Placebo injection 5 minutes before CPB, patients will receive 2 ml of normal saline

Arm

Intervention/Treatment

Experimental: Treatment group

24 patients

Drug: dexchlorpheniramine (Polaramine®) injection

5 minutes before CPB, patients will receive 10 mg (2 ml) of Polaramine®

Placebo Comparator: Control group

24 patients

Drug: Placebo injection

5 minutes before CPB, patients will receive 2 ml of normal saline

Outcome Measures

Primary Outcome Measures

Assesment of patients proportion with abnormal ratio of sympathic-parasympathetic balance (>1.2) [Day 0]
The calculation of every ratio will be made by a software in the department
Assesment of patients proportion with abnormal ratio of sympathic-parasympathetic balance (>1.2) [Day 1]
The calculation of every ratio will be made by a software in the department
Assesment of patients proportion with abnormal ratio of sympathic-parasympathetic balance (>1.2) [Day 2]
The calculation of every ratio will be made by a software in the department

Secondary Outcome Measures

Blood dosage of histamine [Day 0]
Immunophenotypage of basophilic polynuclears [Day 0]
Peaks of pressure measure in the lung artery perioperative [Day 0, day 1, day 2]
Assesment of the postoperative complications incidence [Day 28, month 6]
Measure of the amount of fluids delivered [Day 0, day1, day 2]
Measure of the amount of catecholamine infused [Day 0, day 1, day 2]
Duration of hospital stay [Day 28]
Mortality [Day 28, month 6]
Collection of adverse events potentially related to the treatment [Day 0, day1, day 2, day 28, month 6]
Assesment of patients proportion presenting metabolic disease, with abnormal ratio of sympathic-parasympathetic balance (>1.2) [Day 0, day 1, day 2]